Rhythm Pharmaceuticals announces anticipated upcoming milestones

Setmelanotide: Acquired Hypothalamic Obesity: Launch IMCIVREE in the United States for the treatment of acquired hypothalamic obesity pending FDA approval; the FDA’s assigned PDUFA goal date is March 20, 2026; Announce topline data in the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired HO in the first quarter of 2026. Congenital HO: Complete enrollment in the setmelanotide Phase 3 trial substudy in congenital HO in the first half of 2026. Genetically Caused MC4R Pathway Diseases: Announce topline data in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases in the first quarter of 2026. Prader-Willi Syndrome: In December 2025, Rhythm announced positive preliminary data for the exploratory phase 2 trial of setmelanotide in patients with PWS that showed BMI and hyperphagia reductions at month 3 and month 6, as well as safety and tolerability consistent with setmelanotide’s well-established clinical profile. Rhythm anticipates announcing six-month results from 18 patients from the ongoing Phase 2 trial in the first half of 2026. Bivamelagon: Pending further feedback from U.S. and European regulatory agencies, initiate a pivotal Phase 3 trial evaluating bivamelagon in acquired HO in 2026. RM-718: Complete enrollment in the Phase 1, Part C trial evaluating the weekly, MC4R agonist RM-718 in patients with acquired HO in the first quarter of 2026.